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New Epilepsy Drug Approved by FDA

In October 2016, the U.S. Food and Drug Administration approved Carnexiv™ (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received orphan drug designation for this indication and will be the first available intravenous formulation of the antiepileptic drug (AED) carbamazepine. Global pharmaceutical company Lundbeck plans to make Carnexiv commercially available in the United States in early 2017.

College of Pharmacy researchers helped conduct early clinical proof-of-concept studies, which were instrumental in developing the formulation of Carnexiv, making intravenous administration possible. Researchers James Cloyd, Angela Birnbaum and Ilo Leppik partnered closely with Lundbeck during the clinical trial and approval process for Carnexiv.

Partial seizures and generalized tonic-clonic seizures can often be difficult to control. As a result, many patients with epilepsy are on a daily regimen of one or more AEDs that has been carefully adjusted to obtain a therapeutic response. Switching or an abrupt discontinuation of AEDs can lead to seizure recurrence or breakthrough seizures.

“Carbamazepine is very difficult to make as an aqueous-based injectable formulation, which means that doctors have not had an IV formulation of the drug available when needed,” said Cloyd, director of the Center for Orphan Drug Research.

“This approval is the result of years of work to create a novel and stable injection formulation to support patients who need an alternative to oral carbamazepine. We’re proud to partner with Lundbeck and appreciate the company’s dedication to overcoming development challenges and making this therapy option available for patients and clinicians.”

Carnexiv is the second drug product for epilepsy whose development originated with the University epilepsy research group. The first was rectal diazepam (Diastat).